Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial

Summary

This clinical trial studies whether a healthy living intervention (HLI), with or without a physical activity intervention (PAI), helps maintain the ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment. Early detection and enhanced therapies for breast cancer have improved 5-year cancer-related survival rates. Unfortunately, many breast cancer survivors are at high risk for long-term exercise intolerance, decreased heart health, and lower quality of life following chemotherapy. Currently, there are no effective therapies to help patients maintain these areas throughout chemotherapy. The HLI in this study includes virtual health education classes, which provide useful information on topics like proper nutrition, managing stress, and sleep practices. This may help patients understand the importance of living a healthy lifestyle during chemotherapy. The PAI in this study consists of virtual exercise sessions personalized to the needs of the patient, which may make it easier for patients to stay active during chemotherapy. HLI with PAI may be a more effective way to help maintain ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage II Breast Cancer AJCC v8
• Anatomic Stage III Breast Cancer AJCC v8
• Breast Carcinoma
• Breast Inflammatory Carcinoma
• Locally Recurrent Breast Carcinoma

Interventions

OTHER

Exercise Intervention

Attend virtual personalized exercise sessions

OTHER

Educational Intervention

Attend organized health workshops

OTHER

Supportive Care

Receive Fitbit device, resistance bands, and/or loaner tablet

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Magnetic Resonance Imaging

Undergo CMR

PROCEDURE

Magnetic Resonance Imaging

Undergo ExeCMR

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Accelerometry

Ancillary Studies

OTHER

Electronic Health Record Review

Ancillary Studies

OTHER

Cardiopulmonary Exercise Testing

Undergo CPET

Sponsors & Collaborators

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Glenn Lesser, MD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-05

Primary Completion

2029-09-01

Completion

2030-01-31